CN113038910A

CN113038910A - Fluid collecting device

Info

Publication number: CN113038910A
Application number: CN201980040843.5A
Authority: CN
Inventors: 弗雷德·阿科斯塔
Original assignee: Acosta Medical Group
Current assignee: Acosta Medical Group
Priority date: 2018-04-17
Filing date: 2019-04-17
Publication date: 2021-06-25
Anticipated expiration: 2039-04-17
Also published as: US11413184B2; WO2019204465A1; JP2021522031A; JP7439048B2; EP3781091A4; EP3781091A1; BR112020021354A2; CA3097729A1; US20220387209A1; CN113038910B; US20190314189A1; MX2020011069A

Abstract

The disclosed embodiments relate to a collection device for bodily fluids including a tubular material having a first end and a second end. A portion of the first end is configured to be secured to a user, and the tubular material may be folded over itself to form a first sheath and a second sheath. In some applications, the described fluid collection device may be secured to a user using an interlocking ring.

Description

Fluid collecting device

Cross-referencing of related applications

This application claims priority from U.S. provisional application No.62/7658,793 filed on day 17, 2018 and U.S. provisional application No.62/770,031 filed on day 20, 2018, the disclosure of each of which is incorporated herein by reference.

Technical Field

The embodiments described herein are for body fluid (bodily fluid) collection and protection of a body fluid collection device.

Background

Conventional external catheters and body fluid collection devices typically employ a sheath that can allow urine, blood, feces, or other body fluid to remain in contact with the user for an extended period of time. This can irritate the skin of the user and, in some cases, can lead to infection.

Disclosure of Invention

The disclosed embodiments relate to a collection device in which a single piece of tubular material is folded back upon itself to form a first sheath and a second sheath that is outside of the first sheath and extends generally beyond the open end of the first sheath. At least a portion of the first end of the tubular material is configured to be directly or indirectly attached to a user. The second sheath will define an interior volume in which fluid can be collected and/or directed to a subsequent collection device, such as a fluid bag.

Further disclosed embodiments relate to a body fluid collection device that includes a plurality of individually sealable pouches. These sealable pouches can be closed and separated from the rest of the pouch to form a fluid collection pouch that can be used for extended periods of time while still allowing the removal of bodily fluids.

Further disclosed embodiments relate to a device for protecting an internal catheter and/or drain. The disclosed embodiments may be attached to a user, surrounding the drain, in order to reduce or prevent the catheter or internal drain from falling out and/or becoming contaminated.

Drawings

Fig. 1 depicts one embodiment of the disclosed male fluid collection apparatus.

Fig. 2 illustrates one embodiment of the disclosed male fluid collection apparatus during installation.

Fig. 3 illustrates one embodiment of the disclosed male fluid collection apparatus during installation.

Fig. 4 illustrates one embodiment of the disclosed male fluid collection apparatus during installation.

Fig. 5 illustrates an exemplary embodiment of the disclosed male fluid collection apparatus.

Fig. 6 illustrates an exemplary embodiment of the disclosed male fluid collection apparatus.

Fig. 7 illustrates an exemplary embodiment of the disclosed female fluid collection device during installation.

Fig. 8 illustrates one embodiment of the disclosed female fluid collection device during installation.

Fig. 9 illustrates an exemplary embodiment of the disclosed female fluid collection device.

Fig. 10 illustrates an exemplary embodiment of the disclosed rectal collection device during installation.

Fig. 11 illustrates one embodiment of the disclosed rectal collection device during installation.

Fig. 12 illustrates an exemplary embodiment of the disclosed rectal collection device.

Fig. 13 illustrates an exemplary embodiment of the disclosed protective device during installation.

Fig. 14 illustrates one embodiment of the disclosed protective device during installation.

Fig. 15 illustrates an exemplary embodiment of the disclosed protective device.

Fig. 16 illustrates an exemplary embodiment of the disclosed protective device.

FIG. 17A illustrates a first sheath having a fluttering valve according to an exemplary embodiment.

FIG. 17B illustrates a first sheath with an in-line flutter valve according to an exemplary embodiment.

FIG. 17C illustrates an exemplary embodiment of a first sheath and a second sheath with a flutter valve.

Fig. 18 depicts an exemplary embodiment with an extended second sheath.

Fig. 19 depicts an exemplary embodiment of an extended fluid collection bag.

Fig. 20 depicts an exemplary embodiment of the disclosed device with an extended first sheath.

Fig. 21 depicts an exemplary embodiment of the disclosed device with adhesive attachment.

Detailed Description

The following description of the embodiments provides non-limiting illustrative examples, and reference is made to the accompanying drawings to describe in detail the features and teachings of the various aspects of the invention. From the description of the embodiments, it is contemplated that the described embodiments can be implemented alone or in combination with other embodiments. Those of ordinary skill in the art, with access to the description of the embodiments, will be able to learn and understand the various described aspects of the present invention. The description of the embodiments should be helpful in understanding the present invention to the extent that other implementations not specifically contemplated but within the knowledge of one of ordinary skill in the art having read the description of the embodiments will be understood to be consistent with the application of the present invention.

The disclosed embodiments relate to fluid collection devices. Various embodiments may be configured to function as a male urine collection device, a female urine collection device, a fecal and/or rectal collection device, and/or a device for collecting wound exudate or other bodily fluids. Additionally or alternatively to collecting body fluids, the disclosed embodiments may function to isolate body fluids from the user, thereby limiting skin irritation and infection risk. Some embodiments are designed to isolate an indwelling catheter, surgical drain, or other drain from contaminants.

The disclosed embodiments utilize a tube-in-tube design that forms a first jacket and a second jacket from a single piece of tubular material having a first open end and a second open end. A portion of the first side and/or the first open end can be attached to a user, and the second open end can be folded back onto the first portion of the tubular material to form an inner first sheath and an outer second sheath. This may alternatively be described as folding a portion of the first open end inwardly and attaching a portion of the first open end to the user. Additional tubular material is then rolled or slid onto the user to form a first inner sheath and a second outer sheath.

The disclosed embodiments allow for the formation of various lengths of the first jacket. The various longer and shorter lengths of the first sheath allow this design to accommodate male and female users as well as rectal, wound care, and other embodiments. In some embodiments, the first sheath may be a substantially flat portion of tubular material that adheres to the user, with little or no tubular material extending beyond the user's body. In other embodiments, a small amount of the tubular material will extend beyond the user's body. In some embodiments, the extended tubular material forms a flutter valve that allows fluid to escape but generally does not allow return. In still other embodiments, the bulk of the tubular material will extend away from the user. In various embodiments, the first sheath may be at least about 0.5 inches long, or at least about 1 inch long, or at least about 2 inches long, or at least about 4 inches long, or at least about 6 inches long, or at least about 8 inches long, or at least about 10 inches long. In some embodiments, the first sheath may be up to about 0.5 inches long, or up to about 1 inch long, or up to about 2 inches long, or up to about 4 inches long, or up to about 6 inches long, or up to about 8 inches long, or up to about 10 inches long.

For purposes of example only, the disclosed device is initially described as a male urine collection device, however, there are many alternative uses and embodiments, some of which are described herein. Elements and features described in the context of a male urine collection embodiment are not limited to such an embodiment or application, and may be applied in the context of many other embodiments and applications. Other embodiments will be readily understood and envisioned by those of ordinary skill in the art having access to the present disclosure.

FIG. 1 illustrates an exemplary embodiment of a male urine collection device. As shown in FIG. 1, a portion of the first end of the tubular material is attached to the penis. The first sheath 105 may be adhesively attached directly to the skin of the penis. In some embodiments, the intermediate layer 110 (such as a hydrocolloid dressing, Tegaderm (breathable adhesive film), and/or Duoderm (a dressing) may be adhered directly to the penis, and the first sheath 105 of tubular material may be adhered to the intermediate layer 110.

If the first sheath 105 of material is adhesively attached to the skin of the penis or the intermediate layer 110, such an adhesive attachment may serve as a seal preventing urine and/or other bodily fluids from flowing between the skin of the penis and the first sheath 105. This helps to prevent potential irritation or infection of the skin. In some embodiments, the middle layer 110 may be shaped as a generally circular umbrella with a central opening to allow urine or other bodily fluids to pass through the opening in the middle layer. Preferably, the first sheath 105 is attached to the glans of the penis, and more preferably, the material is attached less than about 0.5cm from the urethral meatus. In some embodiments, the adhesive attachment of the first sheath may allow the user to move or lie on his back while still preventing significant contact between the user and any collected urine or other bodily fluids. In some embodiments, a jelly seal, hydrocolloid dressing, or other moisture barrier may be used between the skin of the penis and the first sheath 105 to form a moisture barrier to further prevent contact between urine or other bodily fluids and the skin of the user. In some embodiments, a jelly seal, hydrocolloid dressing, or other moisture barrier may be attached to the intermediate layer that is attached to the penis. In some embodiments, a jelly seal may be used as the intermediate layer. In some embodiments, a jelly seal may be applied around the head of the penis and/or along the length of the penis to prevent contact between the user's skin and bodily fluids. It should be understood that the disclosed jelly seal and/or intermediate layer may be used with all of the other embodiments described herein. Although the present invention is described primarily with respect to a male urine collection device, all of the disclosed features can also be applied to other embodiments.

In some embodiments, the first opening 115 of the first sheath 105 may be adhered to the penis such that a portion of the penis extends through the first opening 115 of the first sheath 105, as shown in fig. 1. In other embodiments, the first sheath is secured to the penis such that a portion of the first sheath extends beyond the glans of the penis. In such embodiments, the tubular material extending beyond the glans of the penis may be configured to act as a check valve or a flutter valve, which allows fluid to easily exit the first sheath, but generally prevents fluid from entering the first sheath.

FIG. 1 illustrates an exemplary embodiment of the disclosed male urine collection device. As shown in FIG. 1, the first sheath 105 may be positioned over the penis of the user with the first opening 115 adhesively secured around the urethral meatus. The first sheath 105 is secured in place using a first retaining ring 120 and a second retaining ring 125. The second sheath 130 may be folded over the first retaining ring 120. The inner diameter of the second retaining ring 125 is smaller than the outer diameter of the inner retaining ring, and the second retaining ring may be attached to the strap 135 with a strap 140. Second sheath 130 may extend beyond first sheath 105 and connect to collection bag 145. In some embodiments, the second sheath 130 can be attached to the drain tube 150 using a one-way valve 155.

Fig. 2 shows an exemplary embodiment of the disclosed apparatus when installed. As shown in fig. 2, a first sheath 210 of tubular material may be secured to a user with an adhesive 220. The remaining material of the tubular material may be folded over the first sheath 210 to form the second sheath 230.

Fig. 3 shows an exemplary embodiment of the disclosed apparatus being installed. As shown in fig. 3, the first retaining ring 320 may be slid over the penis outside the first sheath 310 when the first sheath 310 is secured to the user. The first sheath 310 may be secured to an intermediate layer 340, which is itself secured to the user. When the remaining tubular material is folded over the first sheath 310, the second sheath 330 will be outside the first retaining ring 320 and the first sheath 310.

The first ring has an inner diameter and an outer diameter and is used to maintain the device in place on a user. The inner diameter of the retaining ring is smaller than the outer diameter. The first retaining ring may be a generally circular ring, but may also be any other shape including, but not limited to, square, rectangular, triangular, and irregular. The term "diameter" is not intended to limit the retaining ring to a circular or elliptical configuration. In some embodiments, the ring is generally sized to fit around the penis, but many different sizes and configurations may be used depending on the conditions and circumstances. In some embodiments, the inner diameter may be at least about 1/2 inches, at least about 1 inch, at least about 2 inches, at least about 4 inches, at least about 6 inches, or greater. In some embodiments, the inner diameter may be up to about 1/2 inches, up to about 1 inch, up to about 2 inches, up to about 4 inches, up to about 6 inches, or less. In some embodiments, the first retention ring 320 is configured to avoid compression of the penis. This may avoid potential complications to the penis of the user associated with reduced blood flow.

In certain embodiments, the retaining ring may be at least about 1/8 inches thick, at least about 1/4 inches thick, at least about 1/2 inches thick, at least about 1 inch thick, at least about 1¹/₂Inches thick, at least about 2 inches thick, or more. In some embodiments, the retaining ring may be up to about 1/8 inches thick, up to about 1/4 inches thick, up to about 1/2 inches thick, up to about 1 inch thick¹/₂Inches thick, up to about 2 inches thick, or less. The outer diameter will vary depending on the inner diameter and overall thickness of the retaining ring.

Fig. 4 illustrates the installation of the example embodiment. As shown in fig. 4, the second end of the tubular material may be folded over onto itself, forming a second sheath 410 outside the first sheath 420 and outside the first retaining ring 430. Once formed, the second sheath 410 defines an interior volume that, in this embodiment, contains the first retaining ring 430, the first sheath 420, and the penis of the user. The second sheath 410 may be configured to extend beyond the opening in the first sheath 420 and beyond the glans of the penis. Second retaining ring 440 may be slid over second sheath 410 and engaged with first retaining ring 430. As the tubular material is folded over itself, the interior volume defined by the second sheath 410 is sealed except for the first opening in the first sheath 420 and the second opening in the second sheath 410. This arrangement prevents urine or any other fluid from leaking out of the device except through the opening in the second sheath 410, which is normally connected to the drain tube. Furthermore, when the first opening in the first sheath 420 is adhered to the end of the penis, urine is separated from the rest of the penis, so that very little skin of the user is exposed to urine or other bodily fluids. In some embodiments, the second opening may be selectively attached to and/or detached from the drain tube using a coupler, a strap, an elastic band, or an adhesive tape.

FIG. 5 illustrates an exemplary embodiment of the disclosed male urine collection device. As shown in fig. 5, the second retaining ring 510 may be positioned outside of the second sheath 520. The second retaining ring 510 has an inner diameter and an outer diameter. The inner diameter of the second ring 510 is smaller than the outer diameter of the first ring 530 in at least one dimension. Due to the relative sizes of the first and second retaining rings, the first ring 530 will not easily pass through the second retaining ring 510. In some embodiments, the second retaining ring 510 is configured to attach to a strap 540 or other means for attaching the second ring 510 to a user. The waist belt and/or belt 540 used to secure the second retaining ring 510 to the user may be elastic or inelastic. The second retaining ring 510 may include attachment points for attaching a waist belt or belt. The second retaining ring 510 may be positioned outside of the second sheath 520. The first retaining ring 530 may be located between the first sheath 550 and the second sheath 520 and closer to the user's body than the second retaining ring 510. In this arrangement, as shown in fig. 5, the first retaining ring 530 will be held in place between the user's body and the second retaining ring 510, and due to their relative size, the first retaining ring 530 will not easily pass through the second retaining ring 510. The second retaining ring 510 may be secured to the user using a strap 540 and a strap 560. The waist band or strap 540 affixed to the second retention ring 510 may be configured to avoid over-stressing the patient and/or may be configured to allow the patient to move freely without displacing the second retention ring 510.

As shown in FIG. 5, in some embodiments, first sheath 550 may be secured to the user using an intermediate layer 570. An indwelling catheter, such as, for example, a Foley catheter or a drain for an indwelling catheter 580, may exit the urethra of the user and pass through the opening in the first sheath 550 into the volume defined within the second sheath 520. In such embodiments, indwelling catheter 580 is substantially isolated from the external environment, thereby reducing the risk of infection at the catheter site.

In one non-limiting example, if the user is already fitted with an internal catheter, such as, for example, a foley catheter, in some embodiments, the first opening of the first sheath may be adhesively attached to the glans of the user's penis.

The tubular material of the exemplary embodiments can be folded over itself to form a second sheath as described herein. The drain of the catheter may exit the penis of the user into the volume defined within the second sheath. The second opening in the second sheath can be selectively sealed around a lower portion of the catheter drain. In this exemplary arrangement, the location of the foley drain away from the user's body is contained within the sealed space defined by the second sheath. The device may be secured to the user using the first and second retaining rings as described above. This allows embodiments of the disclosed fluid collection device to remain in place without affecting the use of the internal conduit, while reducing the risk of contamination or infection. It should be understood that some drain protection embodiments are equally useful for protecting female internal conduits, surgical drains, and other conditions where a drain is removed from a user's body.

FIG. 6 illustrates an exemplary embodiment of the disclosed male urine collection device utilizing a flutter valve. The exemplary embodiment of fig. 6 shows a first sheath 610, a first retaining ring 620, a second sheath 630, and a second retaining ring 640. The second retaining loop 640 is attached to the strap 650 with a strap 660. The first sheath 610 extends beyond the glans of the penis and terminates in a flutter valve 670. The flutter valve 670 allows urine from a user to exit the space inside the first sheath 610 and prevents the urine from re-entering the space inside the first sheath 610. This arrangement may allow urine to exit the user and flow into the volume defined within the second sheath 630, thereby preventing urine or other fluids from significantly contacting the user's skin. In some embodiments, a jelly seal 680 may be applied between the user's skin and the first sheath inside the first sheath 610. The jelly seal 680 may prevent any fluid from migrating along the interior of the first sheath, thereby further isolating the user's skin from contact with urine or other fluids. In some embodiments, a jelly seal 680 may also be applied between the first sheath and the second sheath to facilitate the flow of urine away from the user.

In some embodiments, one end of the strap or belt may be attached to the second retaining ring, while the other end may be adhesively secured to another area of the user's body, either directly or with an intermediate layer (such as a hydrocolloid dressing). In certain embodiments, the belt strips may be adhesively secured to the legs, thighs, buttocks and/or buttocks of the user. In some embodiments, the strap and/or belt is attached to the user without adhesive. This arrangement allows the fluid collection device to be held in place without the need to adhere the device to the user's pelvis and/or without the need for the user to shave hair.

Many embodiments attempt to minimize the amount of user's skin that is substantially isolated from the circulating airflow. This may be achieved by using a retaining ring made entirely of mesh or mesh-like material or by using a retaining ring enclosed in a mesh material, thereby allowing airflow between the retaining ring and the user's skin. In some preferred embodiments, the retaining ring will be constructed of a flexible or resilient material to enhance comfort. The retaining ring may be made of materials including, but not limited to, metals, polymers, rubbers, silicones, cloths, fabrics, mesh materials, and combinations thereof.

The second opening of the second sheath is typically connected to the drain tube. This allows fluid to be removed from the volume defined by the second sheath and transferred into the collection bag. In some embodiments, the second opening is selectively attachable to or detachable from the drain tube, thereby allowing the drain tube to be replaced without removing the fluid collection device. Such selective attachment may be accomplished with couplers, straps, elastic materials, and/or adhesives.

In some embodiments, adhering a portion of the first end of the tubular material to the penis directly or indirectly with the intermediate layer and securing the device with the disclosed first and second retaining rings allows the disclosed male urine collection device to be used without compressing or substantially compressing the penis.

Some disclosed embodiments may be used as an external female urine collection device. Such embodiments generally function in a similar manner to the male embodiments described herein, but with certain modifications as would be understood by a person of ordinary skill.

Fig. 7 shows an exemplary embodiment of a female urine collection device having a first sheath 710 that can be adhered or otherwise attached to a user around the urethra of the user. The tubular material may be folded over the first sheath to form a second sheath 720.

FIG. 8 shows an exemplary embodiment of a female urine collection device being installed. As shown in fig. 8, a portion of the first sheath 810 of tubular material may be adhered to the labia, rather than the penis, such that the first opening in the first sheath 810 substantially surrounds the urethra of the user. In some embodiments, the first opening of the first sheath 810 can be adhered to the labia such that the first opening substantially surrounds the urethra, leaving very little, if any, of the tubular material of the first sheath 810 extending away from the user. In other embodiments, the sheath 810 is secured to the labia such that a portion of the first sheath 810 extends outward, thereby creating more of the first sheath that can be used as a fluttering valve.

The tubular material can be adhesively secured to the labia majora, labia minora, and/or other parts of the user's body. In a preferred embodiment, the tubular material is secured to the labia majora less than about 0.5cm from the labia minora. In many embodiments, the adhesive fastening material forms a seal to prevent urine or other bodily fluids from contacting more of the user's skin.

As shown in fig. 8, a first retaining ring 820 may be positioned substantially around the opening of the urethra to retain first sheath 810 that may be adhered to the user. The second retaining ring 830 may be positioned outside of the second sheath 840 and positioned to engage the first retaining ring 820 in a substantially similar manner as described in the context of a male urine collection device. The inner diameter of the second retaining ring 830 is smaller than the outer diameter of the first retaining ring 820.

FIG. 9 shows an exemplary embodiment of a female urine collection device. As shown in fig. 9, the second retaining ring 910 may be secured to the user using a strap 920 and a strap 930. The skilled artisan will appreciate that the elastic waist band or strap 920 may be used with a female user in order to hold the collection device in place, as the first and second retaining loops 940 are not otherwise held in place by the penis of the user. The retaining ring may be oval and/or contoured in any shape to better accommodate the female anatomy. In some embodiments, the first retention ring 940 will be oval and contoured in shape, and the second retention ring 910 may be substantially any suitable shape capable of holding the first retention ring 940 in place as previously described. It should be appreciated that in some embodiments, the first retaining ring and/or the second retaining ring may not be circular. Nevertheless, the term "diameter" is intended to cover the cross-sectional distance from one point on one side of the shape to a point on the other side (substantially opposite), and is not intended to limit the retaining ring to a circular or rounded shape.

As shown in fig. 9, the disclosed female urine collection device may be used with an indwelling catheter 950. The drainage tube of the indwelling catheter 950 may be passed through a first sheath 960 and a second sheath 970, thereby isolating the catheter from the external environment and reducing the risk of infection.

It should be understood that other bodily fluids besides urine may be collected by the disclosed embodiments. In particular, for some disclosed embodiments, menstrual blood or vaginal secretions may be collected.

Certain disclosed embodiments may be used to collect feces and/or other bodily fluids from the rectum and/or colon of a user. As shown in the exemplary embodiment of fig. 10, a single piece of tubular material may be folded over on itself to form a first sheath 1010 and a second sheath 1020. A portion of the tubular material may be secured directly or indirectly to the user with an adhesive 1030 such that the rectum and/or anus of the user is substantially surrounded by the tubular material. In such embodiments, bodily fluids exiting the user may enter the first sheath 1010 and pass through the first opening in the first sheath 1010 into the volume defined by the second sheath 1020. In some embodiments, the bodily fluid may then pass through the second opening in the second sheath 1020 and into a collection bag or other container.

As shown in fig. 11, in some exemplary embodiments, the collection device can be secured to the user using a first retention ring 1110 and a second retention ring 1120. The first retention ring 1110 may be positioned outside of the first sheath 1140 and inside of the second sheath 1150. A second retaining ring 1120 may be positioned outside of the second sheath 1150 and engage the first retaining ring. In some embodiments, the inner diameter of the second retention ring 1120 is less than the outer diameter of the first retention ring 1110. In some embodiments, a hydrocolloid or other dressing may be affixed to the user to reduce irritation of the user's skin. The padding material 1130 may additionally and/or alternatively be adhered or attached to the user and/or the intermediate layer, and the collection device may be affixed to the padding material 1130. In such embodiments, bodily fluids or substances may exit through the first sheath 1140 and into the second sheath 1150. The use of an intermediate layer of dressing and/or backing material may help to form a seal for containing any bodily fluids while at the same time protecting the user's skin and helping to replace the collection device when necessary.

As shown in fig. 12, in some exemplary embodiments, the collection device can be secured to the user using a first retention ring 1210 and a second retention ring 1220. The second retention ring 1220 can be configured to attach to the strap 1230 with a strap 1240. In some embodiments, the first retention ring 1210 can be positioned outside of the first sheath 1230 and inside of the second sheath 1240. A second retaining ring 1220 can be positioned outside of the second sheath 1240 and engage with the first retaining ring 1210 to secure the collection device to the user.

Some disclosed embodiments may be used to collect and/or isolate bodily fluids discharged from a wound or other body part. The drainage fluid may be drained directly from the wound, or may be drained from a surgical drain, such as, for example, a cigarette drain (Penrose drain).

Fig. 13 illustrates an exemplary embodiment of a bodily fluid collection device having a first sheath 1310 that may be adhered or otherwise attached to a user around a wound or other incision through the skin of the user. The tubular material may be folded over the first retaining ring 1330 to form a first sheath 1310 and a second sheath 1320. In such embodiments, the wound, port, or surgical drain may be substantially surrounded by the first sheath 1310, thereby reducing or preventing contamination of the area.

FIG. 14 shows an exemplary embodiment of a body fluid collection device being installed. As shown in fig. 14, a portion of a first sheath 1410 of tubular material may be adhered to a user's body such that a first opening in the first sheath 1410 substantially surrounds a wound, port, or other incision into the user's body. The first retention loop 1420 may be positioned to substantially surround an opening in a user's body to retain the first sheath 1410 which may be adhered to the user directly or with an intermediate layer. The tubular material may be folded around the first retaining ring 1420 to form the second sheath 1430. The second retaining ring 1440 may be positioned outside of the second sheath 1443 and positioned to engage the first retaining ring 1420 in a substantially similar manner as described in the context of the other embodiments disclosed herein. It should be understood that the components, techniques, and features of any of the various embodiments disclosed herein may be applied to any other disclosed embodiment.

Fig. 15 shows an exemplary embodiment of a body fluid collection device. As shown in fig. 15, the tubular material may be held in place with a first retaining ring 1510 to form a first sheath 1520 and a second sheath 1530. A second retaining ring 1540 can be positioned outside of the second sheath 1530 and can be secured to the user with a strap 1550. One of ordinary skill will appreciate that to hold the collection device in place, at least a portion of the band 1550 can be elastic to allow the user to breathe and/or move while still holding the collection device in place. As shown in FIG. 15, in some embodiments, a second sheath 1530 may be connected to a drain 1560 with a one-way valve 1570. Such an embodiment allows bodily fluids to be expelled from the first sheath 1520 and into the volume defined within the second sheath 1530. Fluid may then be discharged through one-way valve 1570 and into drainage tube 1560. In some embodiments, drain 1560 may be connected to a fluid collection bag.

Figure 16 illustrates an exemplary embodiment of a body fluid collection device for use with a surgical drain 1610. As shown in fig. 16, the collection device can be held in place with a first retaining ring 1620 to form a first sheath 1630 and a second sheath 1640. A second retaining ring 1650 can be positioned outside of the second sheath 1640 and can be secured to the user with a strap 1660. As shown in fig. 16, a drain tube from a surgical implant drain 1610 (such as, for example, a cigarette drain) can exit the body of the user into the space inside the first sheath 1630. The drain tube 1610 may then pass through a first opening in the first sheath 1620 and into the space defined within the second sheath 1640. In some embodiments, the opening of the second sheath 1640 may be configured to allow drainage tube 1610 to pass therethrough. In some embodiments, the second sheath 1640 may be configured to be selectively attached to the drain tube 1610. This arrangement isolates the drainage site from the external environment, thereby reducing the risk of infection of the patient. It should be understood that while this embodiment is described with respect to a cigarette drain for collecting bodily fluids from a wound, similar embodiments may be used to protect any drain exiting a user, including but not limited to drains associated with foley catheters or other internal drainage elements.

Example embodiments disclosed herein may include a first sheath and/or a second sheath. In some embodiments, the first sheath and/or the second sheath may be configured to include a flutter valve. FIG. 17A illustrates an embodiment of a sheath 1710 in which a tubular material is configured to form a flutter valve 1720. In some embodiments, the flutter valve can include a portion of tubular material that allows for passive closing. In some embodiments, the tubular material is shaped to have a reduced diameter at the opening. In some embodiments, the flutter valve can be a Helmlich (Heimlich) valve. The flutter valve allows fluid to exit the sheath and prevents any backflow of fluid outside the sheath.

Fig. 17B shows an exemplary embodiment of a sheath 1730 with an in-line flutter valve 1740 and a tip flutter valve 1750. The embedded flutter valve 1740 can be formed substantially as described in the context of the flutter valve 1720 of FIG. 17A, however, the embedded flutter valve 1740 generally does not define an end of a sheath. As shown in fig. 17B, the sheath 1730 continues past the embedded flutter valve 1740 to the tip flutter valve 1750. The use of the embedded flutter valve 1740 creates an additional one-way valve, allowing fluid to be removed from the user. Although fig. 17B illustrates a single in-line flutter valve 1740, some embodiments can include multiple in-line flutter valves within a single sheath. It should be understood that some embodiments utilizing a flutter valve and/or an embedded flutter valve can include materials other than the single piece of tubular material used to form the first sheath and the second sheath.

Fig. 17C illustrates an exemplary embodiment of a fluid collection device having a first sheath 1760 and a second sheath 1770. The first jacket 1760 terminates in a flutter valve 1780. In addition, the second sheath 1770 includes a plurality of in-line flutter valves 1790. It will be appreciated that each flutter valve essentially forms a one-way valve. The sheath, which includes a plurality of flutter valves, substantially forms a plurality of compartments within the sheath. Each such compartment allows fluid to drain to the next compartment downstream and prevents fluid from flowing upstream toward the user. This arrangement allows for a passive system for expelling fluid away from the user's body and preventing subsequent contact of the fluid with the user's body if the user is rolling, moving or in a supine position. In some embodiments, a check valve may be used in addition to one or more flutter valves.

Figure 18 shows an embodiment of a male urine collection device including an extended second sheath. As shown in fig. 18, the exemplary collection device includes a first sheath 1810 formed from a piece of tubular material and an extended second sheath 1820. The first retainer ring 1830 is placed outside of the first sheath 1810 and inside of the second sheath 1820. The second retention loop 1840 is positioned outside of the second sheath 1820 and attached to the strap 1850 with a strap 1860. The first sheath 1810 terminates in a flutter valve 1870. The extended second sheath 1820 includes two embedded flutter valves 1880. Each embedded flutter valve 1880 forms an additional barrier that inhibits backflow of bodily fluids to the user. In some embodiments, a jelly seal 1890 may be placed between the first and

second sheaths

1810, 1820 or between the first sheath 1810 and the skin of the user's penis.

In some embodiments, the extended second sheath forms an integral fluid collection reservoir. Such embodiments may be used in applications where a relatively small volume of bodily fluid is desired to be collected, such as for example urine collection for an ambulatory user who may be incontinent. In some embodiments, the extended second sheath is sealed closed. In some embodiments, the extended second sheath may be open-ended, but clamped or clipped closed to form a sealed fluid reservoir. In some embodiments, the second sheath is at least about 1 foot long, or at least about 2 feet long, or at least about 3 feet long. In some embodiments, the second sheath is at most about 1 foot long, or at most about 2 feet long, or at most about 3 feet long. In some embodiments, the second sheath is configured to extend along the user's legs under the user's clothing and/or attach to the user's body. In some embodiments, the extended second sheath may comprise an absorbent material.

In the exemplary embodiment shown in fig. 18, the extended second sheath is closed at the ends. In some embodiments, the use of an extended second sheath allows the collection device to be used without a drain or fluid collection bag. It will be appreciated that once the extended second sheath is full, this may require removal of the fluid collection device. In some embodiments, the extended second sheath is configured to fluidly connect to a drain and/or a fluid collection bag, thereby allowing the fluid collection device to remain attached to the patient while the fluid collection bag is replaced.

In some exemplary embodiments, the second opening of the second sheath will be configured to attach to a drain tube and/or a collection bag. A typical collection bag comprises a single pouch that can be removed and replaced. Fig. 19 shows a collection bag having a plurality of tongue and groove seals 1910 within the body 1920 of the collection bag. These seals may be configured to form individually sealable pockets 1930. In some embodiments, multiple pairs of tongue and groove seals 1910 can be used to form a separately removable pouch.

In some embodiments, two adjacent tongue and groove seals may be sealed closed to form a sealed pouch. The lower seal of an adjacent pair of seals forms a sealed top of the lower pouch, and the upper seal of the pair of seals forms a sealed bottom of the upper pouch. Once the two seals are securely closed, the lower pouch may be removed from the collection bag by cutting the portion of the collection bag between the two seals.

By removing the lower reservoir bag from the rest of the fluid collection bag, the weight associated with any collected body fluid may be reduced, thereby reducing the risk of the fluid collection device falling out. Removal of the weight may also facilitate movement by the user. By allowing a portion of the collection bag to be removed, an extended collection bag can be used without frequent replacement. This arrangement may save material and time associated with replacing the collecting bag.

Some disclosed embodiments may be attached to a user without the use of a retaining ring. Fig. 20 shows an exemplary embodiment of a male urine collection device including an extended first sheath 2010. As shown in fig. 20, the extended first sheath may extend along the length of the user's penis. In some embodiments, the extended first sheath may include perforations or a mesh material to provide airflow to the skin of the user. In some embodiments, increasing the surface area between the extended first sheath and the penis of the user may result in sufficient force required to hold the fluid collection device in place without the use of a retaining ring. In some embodiments, the extended first sheath 2010 may be selectively secured to the user's penis with a separate material (such as, for example, medical tape or adhesive material 2030, such as, for example, a hydrocolloid dressing, Tegaderm, and/or Duoderm). In some embodiments, first sheath 2010 is configured to not compress a user's penis.

As shown in the exemplary embodiment of fig. 20, a second sheath 2020 may be attached to the first sheath. In some embodiments, second sheath 2020 may be integral with first sheath 2010. In some embodiments, second sheath 2020 may comprise a single piece of material connected to first sheath 2010. In some embodiments, the second sheath 2020 is connected to the first sheath 2010 at a location that is configured to be under the head of the user's penis when the device is mounted on a patient. In some embodiments, the second sheath 2020 is folded around the head of the penis outside at least a portion of the first sheath 2010.

Some embodiments disclosed herein may be adhesively attached to a user, thereby not relying on a retaining ring. In some embodiments of the male urine collection device, the first end of the first sheath may be adhesively attached to the penis of the user with or without an intermediate layer. In an exemplary embodiment, the first sheath may additionally be adhesively attached to the base of the user's penis. In some embodiments, a breathable, porous, and/or non-irritating adhesive dressing, such as, for example, Hypafix tape, may be used to allow airflow to reach the user's skin. By adhesively attaching the first sheath to the user at two locations, the tubular material can be folded over the adhesively attached first sheath to form a second sheath outside the first sheath. In such embodiments, the first sheath may be adhesively attached to the head or middle shaft portion of the user's penis, in addition to the base portion of the user's penis. It will be appreciated that embodiments of the middle shaft portion that adhere to the penis of a user may be useful for ambulatory users, as urine will naturally flow down and away from the user's skin when the user is sitting or standing, rather than lying supine.

In some embodiments, the male urine collection device may be adhesively secured to the user without the use of a retaining ring or an extended first sheath. As shown in fig. 21, a male collection device comprising a first sheath 2110 and a second sheath 2120 may be initially applied to a user as described above, wherein the second sheath 2120 is folded over the outside of the first sheath 2110. In some embodiments, the first sheath 2110 may be adhesively attached to the glans of the penis with the intermediate layer 2130. Porous tape 2140 (such as, for example, Hypafix tape) may be used to secure the male urine collection device to the shaft portion of the penis. As shown in fig. 21, a piece of adhesive tape 2140 may be applied to the exterior of the second sheath 2120, covering a portion of the collection device where the tubular material is folded over to form the first sheath and the second sheath. The adhesive tape 2140 may also be applied to at least a portion of the shaft portion of the penis to adhesively secure the collection device to the user without the use of a retaining ring. It should be understood that the adhesive tape 2140 may be applied in a manner that avoids compression of the penis or avoids significant compression of the penis.

Some embodiments disclosed herein may include one or more inflatable sections. These inflatable portions may be configured to allow portions of the fluid collection device to float when urine or other liquid collects but is not discharged from the device. In some embodiments, the floating portion prevents or maintains contact of the user's body with the pooled liquid. In some embodiments, the inflatable portion may be inflated using a syringe or a compressed air source. In some embodiments, the inflatable portions may be configured as a single or multiple linear or curved, half-moon, or semi-circular bladders. In the male urine collection embodiment, the inflatable portion should not create excessive pressure around the penis when inflated.

In some embodiments, the hydrophobic coating may be applied to the interior and/or exterior of the tubular material and/or other components of the fluid collection device. In some embodiments, the material used to form the device may be partially or wholly hydrophobic in nature. Such materials may facilitate the flow and/or removal of bodily fluids away from the user.

In some embodiments, a desiccant or superabsorbent material may be included within the device. In some embodiments, a desiccant and/or superabsorbent material may be placed within a fluid collection bag or other container to prevent the movement of any trapped fluid. In some embodiments, a desiccant and/or a superabsorbent material may be used to prevent or minimize contact between the user's skin and any bodily fluids.

Some embodiments include antibacterial, antifungal, and/or antimicrobial coatings and/or materials. In some embodiments, the jelly seal can include an antibiotic, antifungal, and/or antimicrobial agent.

Some embodiments may include a reservoir and an access port that may be used to access a sample of collected bodily fluid. Bodily fluids, such as, for example, urine, may be used to perform a variety of diagnostic tests. These tests include, but are not limited to, pregnancy tests, pH, urine glucose, urine protein, urine chemistry, and/or bacterial culture. In some embodiments, the access port may be formed by, for example, a tongue and groove seal or a portion of a material designed to be pierced by a hypodermic needle.

In some disclosed embodiments, the device is attached to the user using a single retaining ring with magnetic attachment. In such embodiments, the first retaining ring may be magnetized, may have a magnetic component, or may include a metal component and be affixed to a magnetic component attached to the user. In some embodiments, securing the first retaining ring using magnetic attachment eliminates the need for a second retaining ring. It will be appreciated that the part of the base or strap attached to the user and/or the part of the retaining ring may be magnetised in order to secure the fluid collection device to the user. It is not required that both the components of the base and the retaining ring be magnetized.

Disclosed embodiments may relate to a fluid collection apparatus including: a tubular member including a first end having a first opening and a second end having a second opening, a portion of the first end configured to be adhesively secured to a user, and the second end configured to be folded about the first end to form a first sheath and a second sheath, wherein the second sheath is outside the first sheath and defines an interior volume; a first retaining ring having an inner diameter and an outer diameter, the first retaining ring configured to be positioned outside of the first sheath and inside of the second sheath; and a second retaining ring having an inner diameter and an outer diameter, the inner diameter of the second retaining ring being smaller than the outer diameter of the first retaining ring. In some embodiments, the second sheath is configured to attach to a fluid collection bag and/or the second retention ring is configured to attach to a drawstring. Some embodiments further include a strap configured to be positioned around a user and a strap configured to connect the second retention loop to the strap. In some embodiments, the strap comprises an elastic material; the first sheath is configured to extend beyond the glans of the penis and allow the drainage tube to pass through the first opening; the drainage tube is configured to drain fluid into an interior volume defined by the second sheath; the first sheath comprises a flutter valve; the first sheath comprises an embedded flutter valve; and/or the second sheath comprises at least one flutter valve. Some embodiments further comprise: a one-way valve connecting the second sheath to the drain tube, and wherein the drain tube is connected to a fluid collection bag; a fluid collection bag comprising a plurality of tongue and groove seals; and/or an adhesive layer positioned at the first end of the tubular member. In some embodiments, the first retention ring is configured to be positioned around the penis and avoid compression of the penis.

Disclosed embodiments may relate to a male urine collection device, including: a tubular member having a first end and a second end; the tubular member is configured to be folded over itself to form a first sheath and a second sheath, wherein the first sheath is configured to be positioned around the penis and the second sheath is outside the first sheath; wherein the second sheath defines an interior volume and is configured to be in fluid communication with a fluid collection bag; and a first retaining ring having an inner diameter and an outer diameter, the first retaining ring configured to be positioned around the penis outside of the first sheath and inside of the second sheath, the first retaining ring configured to avoid compression of the penis. In some embodiments, the first opening in the first sheath is configured to allow an indwelling catheter drain to pass through the first opening, and wherein the second opening in the second sheath is configured to be secured around the drain. Some embodiments further comprise a second retaining ring having an inner diameter and an outer diameter, the outer diameter of the first retaining ring being greater than the inner diameter of the second retaining ring, and the second retaining ring being configured to be attached to the band by a strap.

Disclosed embodiments may relate to a male urine collection device, including: a first sheath having a first end including a first opening configured to allow insertion of a penis into the first end of the first sheath and a second end including a second opening configured to extend beyond the glans of the penis, and the second opening including a flutter valve; and a second sheath attached to an exterior of the first sheath, the second sheath being outside of the second end of the first sheath and defining an interior volume. In some embodiments, the first end of the first sheath includes a plurality of ventilation openings to allow airflow to reach a portion of the penis and/or the second end of the first sheath includes an adhesive layer.

Throughout the specification and claims, the following terms take at least the meanings explicitly associated herein, unless the context clearly dictates otherwise. The term "or" is intended to mean an inclusive "or". In addition, the terms "a", "an" and "the" are intended to mean one or more, unless otherwise indicated herein or clearly contradicted by context. The term "tubular" is intended to encompass circular, rectangular, irregular, or any other cross-sectional geometry, so long as their components are hollow. The term "tubular" is not limited to circular or circular cross-sections, but includes many variations. The term "diameter" is intended to encompass the distance from one side of the shape to the other, and is intended to encompass any cross-sectional shape. The term "diameter" is not limited to circular or round shapes, but also includes rectangular, angled, and irregular shapes.

In the present specification, numerous specific details have been set forth. However, it is understood that embodiments of the disclosed technology may be practiced without these specific details. In other instances, well-known methods, structures and techniques have not been shown in detail in order not to obscure an understanding of this description. References to "some examples," "other examples," "one example," "an example," "various examples," "one embodiment," "an embodiment," "some embodiments," "example embodiments," "various embodiments," "one implementation," "an implementation," "exemplary implementation," "various implementations," "some implementations," etc., indicate that an implementation of the disclosed technology so described may include a particular feature, structure, or characteristic, but every implementation does not necessarily include the particular feature, structure, or characteristic. Moreover, repeated use of the phrases "in one example," "in one embodiment," or "in an embodiment" does not necessarily refer to the same example, embodiment, or embodiment, although it may.

While certain embodiments of the disclosed technology have been described in connection with what are presently considered to be the most practical and various embodiments, it is to be understood that the disclosed technology is not limited to the disclosed embodiments, but, on the contrary, is intended to cover various modifications and equivalent arrangements included within the scope of the appended claims. Although specific terms are employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation.

This written description uses examples to disclose certain embodiments of the disclosed technology, including the best mode, and also to enable any person skilled in the art to practice certain embodiments of the disclosed technology, including making and using any devices or systems and performing any incorporated methods. The patentable scope of certain embodiments of the disclosed technology is defined in the claims, and may include other examples that occur to those skilled in the art. Such other examples are intended to be within the scope of the claims if they have structural elements that do not differ from the literal language of the claims, or if they include equivalent structural elements with insubstantial differences from the literal languages of the claims.

Claims

1. A fluid collection apparatus comprising:

a tubular member including a first end having a first opening and a second end having a second opening, a portion of the first end configured to be adhesively secured to a user and the second end configured to be folded about the first end to form a first sheath and a second sheath, wherein the second sheath is outside the first sheath and defines an interior volume;

a first retaining ring having an inner diameter and an outer diameter, the first retaining ring configured to be positioned outside of the first sheath and inside of the second sheath; and

a second retaining ring having an inner diameter and an outer diameter, the inner diameter of the second retaining ring being smaller than the outer diameter of the first retaining ring.

2. The fluid collection device of claim 1, wherein said second sheath is configured to be attached to a fluid collection bag.

3. The fluid collection device of claim 1, wherein the second retention ring is configured to be attached to a strap.

4. The fluid collection device of claim 3, further comprising a strap configured to be positioned around a user and a strap configured to connect the second retention loop to the strap.

5. The fluid collection device of claim 4, wherein said strap is elastic.

6. The fluid collection device of claim 1, wherein the first sheath is configured to extend beyond the glans of the penis and allow a drain tube to pass through the first opening.

7. The fluid collection device of claim 6, wherein the drain is configured to drain fluid into an interior volume defined by the second sheath.

8. The fluid collection device of claim 1, wherein said first sheath comprises a flutter valve.

9. The fluid collection device of claim 1, wherein said first sheath comprises an embedded flutter valve.

10. The fluid collection device of claim 1, wherein said second sheath comprises at least one flutter valve.

11. The fluid collection device of claim 1, further comprising a one-way valve connecting the second sheath to a drain, and wherein the drain is connected to a fluid collection bag.

12. The fluid collection device of claim 1, further comprising a fluid collection pouch comprising a tongue and groove seal.

13. The fluid collection device of claim 1, wherein the first retaining ring is configured to be secured around the penis and avoid substantial compression of the penis.

14. The fluid collection device of claim 1, further comprising an adhesive layer positioned at the first end of the tubular member.

15. A male urine collection device comprising:

a tubular member having a first end and a second end; the tubular member is configured to be folded over itself to form a first sheath and a second sheath, wherein the first sheath is configured to be positioned around the penis and the second sheath is outside the first sheath;

wherein the second sheath defines an interior volume and is configured to be in fluid communication with a fluid collection bag; and

a first retaining ring having an inner diameter and an outer diameter, the first retaining ring configured to be positioned around the penis outside of the first sheath and inside of the second sheath, the first retaining ring configured to avoid compression of the penis.

16. The male urine collection device according to claim 15, wherein a first opening in the first sheath is configured to allow an indwelling catheter drain to pass therethrough, and wherein a second opening in the second sheath is configured to be secured around the drain.

17. The male urine collection device according to claim 15, further comprising a second retaining ring having an inner diameter and an outer diameter, the outer diameter of the first retaining ring being greater than the inner diameter of the second retaining ring, and the second retaining ring being configured to be attached to a belt by a strap.

18. A male urine collection device comprising:

a first sheath having a first end comprising a first opening configured to allow insertion of a penis into the first end of the first sheath and a second end comprising a second opening configured to extend past the glans of the penis, and the second opening comprising a flutter valve; and

a second sheath attached to an exterior of the first sheath, the second sheath outside of the second end of the first sheath and defining an interior volume.

19. The male urine collection device according to claim 18, wherein the first end of the first sheath includes one or more vent openings to allow airflow to reach a portion of the penis.

20. The male urine collection device according to claim 18, wherein the second end of the first end includes an adhesive layer.